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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K090891
Device Name MICROPLEX COIL SYSTEM-COSMOS
Applicant
MicroVention, Inc.
75 Columbia
Suite A
Aliso Viejo,  CA  92656 -1408
Applicant Contact Naomi Gong
Correspondent
MicroVention, Inc.
75 Columbia
Suite A
Aliso Viejo,  CA  92656 -1408
Correspondent Contact Naomi Gong
Regulation Number882.5950
Classification Product Code
HCG  
Date Received03/30/2009
Decision Date 06/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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